生物治療藥物對許多疾病的治療帶來革命性的變化，而生物仿制藥亦在醫(yī)療制度中逐漸達(dá)到以少許費(fèi)用發(fā)揮相同的治療效果。

如果生物仿制藥在美國開始獲得核可，對醫(yī)療產(chǎn)業(yè)與病患來說，預(yù)估在未來10年間將可節(jié)省57億美元。不過，生物制劑尚有制造難度等各種問題，而生物仿制藥的開發(fā)上更有多于學(xué)名藥的困難。

此外，暢銷藥生物制劑制造商今后所面臨專利期限到期的問題亦是嚴(yán)重。這些制造商以自家品牌銷售產(chǎn)品的營業(yè)額超過600億美元，而這些產(chǎn)品的專利在未來幾年內(nèi)即將到期。

（Biosimilars & Biobetters USA 2015）

生物仿制藥和第二代產(chǎn)品的產(chǎn)業(yè)，相較于低分子學(xué)名藥產(chǎn)業(yè)，明顯被視為活絡(luò)且具有極大策略重要性，在不斷變化的競爭環(huán)境和法規(guī)環(huán)境中，提升彈性與意愿以活用商機(jī)將變得重要。

美國的生物仿制藥市場在2018年將擴(kuò)大至20億美元的規(guī)模，而該國開始核可生物仿制藥的話，預(yù)料在今后10年的核可件數(shù)將大幅增加、產(chǎn)業(yè)將呈現(xiàn)活絡(luò)。此外，法規(guī)面亦將產(chǎn)生劇烈變化，對于理解在生物仿制藥相關(guān)指引的架構(gòu)中，所發(fā)生的動(dòng)向和立法相關(guān)的美國與歐洲的合作等變得重要。

在美國舉辦本學(xué)會(huì)的目的，為促進(jìn)對于產(chǎn)品生命周期與生物仿制藥研發(fā)所有方面的完整理解。

推薦參加理由：

本學(xué)會(huì)為期2天，將針對以下議題進(jìn)行熱烈討論和意見交換，并可吸收許多知識。

生物仿制藥相關(guān)法規(guī)面環(huán)境以及藥品上市后安全監(jiān)視制度的評價(jià)
生物制劑價(jià)格競爭與創(chuàng)新法的紛爭解決程序之評價(jià)與課題
生物仿制藥之技術(shù)課題的理解與認(rèn)識
生物制劑制造相關(guān)的策略計(jì)畫建立與創(chuàng)新手法導(dǎo)入
生物制劑的現(xiàn)狀－臨床開發(fā)與持續(xù)進(jìn)步
商業(yè)化策略的評價(jià)與市場開發(fā)的改善
對于第二代產(chǎn)品認(rèn)知度的提升與其未來性
免疫原性試驗(yàn)無法預(yù)期之結(jié)果的評價(jià)

推薦參加人士
從事下列業(yè)務(wù)的CSO、CMO社長、副總裁、代表、董事、團(tuán)隊(duì)管理者等千萬不可錯(cuò)過的學(xué)會(huì)

生物醫(yī)藥品／生物治療藥物
生技仿制藥／蛋白質(zhì)仿制藥／生物仿制藥
生物制劑／生物科技／生物學(xué)名藥
法務(wù)／規(guī)范問題
智能財(cái)產(chǎn)權(quán)
醫(yī)療經(jīng)濟(jì)
價(jià)格制定與保險(xiǎn)補(bǔ)助
臨床免疫學(xué)
程序控制與分析技術(shù)
解析評價(jià)
法規(guī)遵守
藥品上市后安全監(jiān)視
醫(yī)藥品的安全性與危機(jī)管理
品質(zhì)問題／品質(zhì)管理
新產(chǎn)品開發(fā)
程序科學(xué)
產(chǎn)品種類管理
研究開發(fā)
事業(yè)開發(fā)
事業(yè)營運(yùn)
科學(xué)領(lǐng)域的問題
商業(yè)領(lǐng)域的問題與策略計(jì)畫建立
立法與政策的建議

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第一天

8.30 ?報(bào)到手續(xù)、茶敘

9.00 ?議長開會(huì)致辭

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9.10 ?FDA對生物相似性確立之品質(zhì)特性統(tǒng)計(jì)分析見解

Ravi S. Harapanhall,iRavi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

9.50??美國可借鑒的歐洲經(jīng)驗(yàn)

Steinar Madsen,Steinar Madsen, Medical Director, Norwegian Medicines Agency

Nine years of biosimilars in Europe – safety and efficacyWhat are the regulatory differences between Europe and the US?How important ?is labelling and naming?Uptake of biosimilars in clinical practice – lessons from Europe

10.30 ?上午休息

11.00 ?特別演講：第一個(gè)被FDA批準(zhǔn)的BIOSIMILAR

John Pakulski,John Pakulski , Senior Director and Head US Biopharmaceutical Regulatory Affairs, Sandoz Inc.

Looking at this case in detail, how did it progress and how will it developHow did the FDA interpret their own guidelines What can we learn from this first approval?Looking ahead, what’s the future regarding more complex molecules?

11.40 ?小組討論：評估全球各地BIOSIMILAR商業(yè)化成功的條件

Magdalena Leszczyniecka,Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

Robin Chadwick,Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

Rakesh Dixit,Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

Gain insights as to what an optimal business model is forglobal commercialization of biosimilars: 1) ?stand alone; 2) generic partnered with Big Pharma or Big Bio; 3)geographical or regional licensees; 4) distributors; 5) consortia Which model for which products? ? 1) first

wave biosimilars 2) second wave biosimilars 3) ?Third wave biosimilars and PD-1sGeographical location – Which model for which region? ?1) Europe; 2) USA; 3) LATAM; 4) APAC; 5) Russia and CIS ??

12.20 ?午餐

13.30 ?持續(xù)發(fā)展的BIOSIMILAR展望

Michael Kleinrock,Michael Kleinrock, Research, Director, IMS Health Inc

The Global Biologic Market: understanding the place of biologics in medicine use around the worldLearning from the biosimilar experience: European experience can offer some insights into the U.S. future (and some confusion too)Looking ahead to the next five years of

biosimilar and biologic evolution

14.10 ?傳統(tǒng)原廠藥與學(xué)名藥之間的模糊界限

Andrea Laslop,Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety

Scientific and quality considerations in demonstrating biosimilarity between the biosimilar and the reference product Reviewing the need to show bioequivalence to the innovator drug based on pharmacokinetic parameters such as rate absorption and bioavailability Understanding the complexity of biosimilar models from a clinical perspective

14.50 ?案例研討：首個(gè)國際參考標(biāo)準(zhǔn)

Michael Tovey,Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan

Importance of reference Standards for the Development of biosimilars ? ? ? First WHO International Standard (IS) for the TNF-alpha sRII receptor-Fc fusion protein (Etanercept). First International Reference (IR) Preparation for anti-drug (anti-Eprex) antibodiesOther WHO IS & IRs for biosimilars currently in development

15.30 ?下午休息

16.00 ?最新趨勢：BIOBETTER或BIOSUPERIOR接受最佳分子及低價(jià)BIOSIMILAR挑戰(zhàn)的可能性

Rakesh Dixit,Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilarsEvaluating the current innovations in improving existing biologics therapies in diseases with unmet medical needsIdentifying which products have significant potential for ‘biosuperior’ developmentDeveloping biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologicsExamining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins?

16.40 ?治療性抗體的生物機(jī)能之醣化影響

Raju Shantha,Raju Shantha, Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.

17.20 ?可互換性相關(guān)重要論點(diǎn)

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

The determination of interchangeability: satisfying the FDA definition to achieve automatic substitution by the pharmacy without physician consultationWill interchangeability minimize the uncertainty of biosimilar adoption?How does INN naming affect automatic substitution?What will the FDA interchangeability guideline look like?Considerations in the design of switching studies #How will interchangeability affect pricing and reimbursement?Differentiation between the designation or practice of interchangeability in the US and EUWhich is more desirable for success: switching existing patients or interchangeability?

18.00 ?議長總結(jié)、第1天閉幕

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

第二天

8.30 ?報(bào)到手續(xù)、茶敘

9.00 ?議長致辭

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

9.10 ?歐洲專利訴訟現(xiàn)況

Dominic Adair,Dominic Adair, Partner, Patent Litigation, Bristows

The patent cliff and the patent hurdle – is it real?

When litigation begins, are the rules different?

Patent challenges in Europe – the EPO and the national courts

The future landscape – the Unified Patent Court

9.50 ?生物制劑價(jià)格競爭及BPCI爭議解決流程的替代方法

Jim NelsonJim, Nelson, Senior Principal and Owner, Adversarial?
Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner

Reviewing the use of IPR at the US PTO PTAB as an alternative to the Patent?
Dance of the BPCI Act?

Claim term interpretation, what do these words mean?

Touching on the use of amendments

10.10 ?于美國取得BIOSIMILAR販?zhǔn)蹤?quán)之BPCI與FDA所設(shè)定要件評估

Robin Chadwick,Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

Discussing semi-automated processes to identify and analyze US patents of interest to answer the question whether such patents should be listed on the biosimilar applicant’s proposed list of patents during the BPCI exchange

10.30 ?上午休息

11.00 ?案例研討：透過使用免疫耐受性奈米粒子的免疫原性對策提高療效與安全性之BIOBETTER開發(fā)

Takashi Kei ?Kishimoto, Takashi Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

The forthcoming flood of biosimilars will create a highly competitive, low margin marketplace. There will be a competitive advantage for biobetters that are differentiated based on their efficacy and safety profile

Anti-drug antibodies compromise the utility of many biologic drugs by neutralizing drug efficacy, modulating pharmacokinetics, and/or causing adverse events

We have developed tolerogenic synthetic vaccine particles (SVP) that are capable of inducing durable immune tolerance to biologic drugs. We will present case examples using tolerogenic SVP with adalimumab and pegylated uricase

11.40 ?指紋辨識法－加促BIOSIMILAR研發(fā)

Magdalena Leszczyniecka,Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

Because of the very high cost and length of time associated with biologics development, access to biosimilars at a lower cost with shorter development timelines would make these treatments more accessible to a greater number of patients?

To realize cost and time savings from biosimilars, the current development model needs to change to follow the generic product development paradigm which requires only one bioequivalence trial

STC is currently working on fingerprinting approach to obtain approval on a biosimilar antibody product with only one clinial trial through the use of fingerprinting platform. This concept is described in a detailed publication by FDA’s Steve Kozlowski, indicating that a rigorous “fingerprint” like analytical and nonclinical pharmacological similarity could help lift many of the uncertainties/risks of the biosimilar product compared to the originator, which would decrease the burden of clinical trials conducted only to address any“residual uncertainty” not addressable by in vitro studies

12.20 ?午餐

13.30 ?美國的商機(jī)－2018年前預(yù)測

Cliff Mintz,Cliff Mintz, Senior Writer/Correspondent, Life Science Leader
Strengthening long-term strategy to maximise return on investment and to benefit patients

How to seek partnership to develop and execute risk mitigation strategies?
Forecasting market penetration – What are the factoring barriers to entry?

14.10 ?因應(yīng)歐美與亞洲多種需求的臨床開發(fā)與法規(guī)遵守策略

Gerry McGettigan,Gerry McGettigan, Founder & Director, Kinesys Consulting

What are the key features of a truly global development programme?

What obstacles should US / EU biosimilars companies be aware of in Asia and emerging markets

What changes do we need in development and regulatory requirements to facilitate truly global developments, and which stakeholders need to make these changes happen?

14.50 ?降低BIOSIMILAR制造商風(fēng)險(xiǎn)與有助擴(kuò)大商機(jī)的合作關(guān)系

Mina ?Song,Mina Song, Director- Alliance Management, Biosimilars, Merck and Co.

How approaches could help big and small players to mitigate risks

Different partnering models

Learnings from experience

15.30 ?下午休息

16.00 ?案例研討：BIOSIMILAR產(chǎn)業(yè)現(xiàn)況與未來展望

Carsten Brockmeyer,Carsten Brockmeyer, CEO, Formycon AG

Biosimilars will soon become number one products – but how to get there?

Lessons learned from the first European & US biosimilars

Creating a true global biosimilars strategy

Similarity exercise, clinical data, extrapolation

Monoclonal antibodies, a new milestone for the biosimilars market

Why biosimilars have been more successful than biobetters

Challenges and opportunities with third wave biosimilars

16.40 ?新興國家市場評估與策略強(qiáng)化

Sean Xue,Sean Xue, Director Portfolio Management, Dr Reddy's Laboratories

How are emerging markets shifting in BRIC countries?

Dealing with cost containment?

How do emerging markets compare to the EU and US regulations

17.20 ?議長閉幕致辭、第2天閉幕

Richard Dicicco,Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

* 活動(dòng)內(nèi)容有可能不事先告知作更動(dòng)及調(diào)整。

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Conference：USD 1,799?? ?

Workshop - A Regulatory Perspective for Biosimilar：USD 599?? ?

Workshop -Development, Regulatory and Commercial Needs for Global Biosimilars：USD 599?? ?

Promotional Literature Distribution(UK Local Tax 20% is added),USD 1,598?? ?